Clinicians perform many medical procedures by puncturing a blood vessel and introducing a small tube through the blood vessel that is guided to other parts of the body. A common point of entry is the femoral artery. Once the medical procedure is completed, the artery or other blood vessel has to be adequately closed so the patient can leave the operation site, and the puncture needs to heal.
Many devices have been created to facilitate closure after iatropic punctures have been made in the femoral artery. Examples include devices described in U.S. Pat. Nos. 5,108,421 to Fowler, 5,192,302 or 5,222,974 to Kensey, and US Pub 2006/0100664 to Pai. The PERCLOSE system, introduced in 1994, was the first suture-mediated device to be approved by the Food and Drug Administration. PERCLOSE PROGLIDE is the latest generation, introduced in 2004. It offers improvements in the ease of knot delivery and strength and of the suture material. The system is composed of a sheath, a guide, a knot pusher accessory, and a suture trimmer. The ANGIO-SEAL device is made up of three components: a specially designed polymer anchor, an absorbable collagen sponge, and an absorbable self-tightening suture. The sponge is positioned in the puncture track outside the artery wall by a pulley system created by the anchor and suture. The device seals and sandwiches the arteriotomy between the anchor and the collagen plug. The STARCLOSE is a clip-mediated closure device approved by the Food and Drug Administration in 2005. The STARCLOSE introduces a small, circumferential, flexible clip that mechanically binds the surface of the femoral artery together. The clip is made of nitinol, a nickel-titanium alloy with elastic properties that allow it to return to its original shape once released from the device. Its use involves a multi-step deployment process with a specialized application. The clip is left on the outside of the artery. The MYNX is a rolled-up biodegradable polymer sheet that is pushed into the puncture track and allowed to swell. The swelling secures the device and prevents blood flow.